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Review
. 2022 Nov;12(11):4075-4097.
doi: 10.1016/j.apsb.2022.08.025. Epub 2022 Sep 5.

Emerging biotechnology applications in natural product and synthetic pharmaceutical analyses

Shilin Chen  1   2 , Zheng Li  3 , Sanyin Zhang  4 , Yuxin Zhou  1   2 , Xiaohe Xiao  5 , Pengdi Cui  3 , Binjie Xu  4 , Qinghe Zhao  2 , Shasha Kong  2 , Yuntao Dai  2
Affiliations
Review

Emerging biotechnology applications in natural product and synthetic pharmaceutical analyses

Shilin Chen et al. Acta Pharm Sin B. 2022 Nov.

Abstract

Pharmaceutical analysis is a discipline based on chemical, physical, biological, and information technologies. At present, biotechnological analysis is a short branch in pharmaceutical analysis; however, bioanalysis is the basis and an important part of medicine. Biotechnological approaches can provide information on biological activity and even clinical efficacy and safety, which are important characteristics of drug quality. Because of their advantages in reflecting the overall biological effects or functions of drugs and providing visual and intuitive results, some biotechnological analysis methods have been gradually applied to pharmaceutical analysis from raw material to manufacturing and final product analysis, including DNA super-barcoding, DNA-based rapid detection, multiplex ligation-dependent probe amplification, hyperspectral imaging combined with artificial intelligence, 3D biologically printed organoids, omics-based artificial intelligence, microfluidic chips, organ-on-a-chip, signal transduction pathway-related reporter gene assays, and the zebrafish thrombosis model. The applications of these emerging biotechniques in pharmaceutical analysis have been discussed in this review.

Keywords: Biotechnology; Manufacturing control; Pharmaceutical analysis; Quality analysis; Raw materials.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Image 1
Graphical abstract
Figure 1
Figure 1
Overview of current pharmaceutical analysis methods.
Figure 2
Figure 2
Emerging biotechnologies and bioinformatics for pharmaceutical analysis.
Figure 3
Figure 3
Biotechnological methods to detect raw materials.
Figure 4
Figure 4
Biotechnologies in pharmaceutical manufacturing process control and intermediate analysis.
Figure 5
Figure 5
Overview of biological techniques used in drug safety evaluation.
Figure 6
Figure 6
Bioassays in effectiveness analysis.
Figure 7
Figure 7
Biotechniques for pharmaceutical quality control analysis.
See this image and copyright information in PMC

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